SUPARTZ device family, SUPARTZ FX and VISCO-3

FDA Premarket Approval P980044 S056

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Sharing the facility and equipment used to manufacture supartz fx and visco-3 for the purpose of the manufacturing the intermediate of gel-one

DeviceSUPARTZ device family, SUPARTZ FX and VISCO-3
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantSEIKAGAKU CORP.
Date Received2021-04-28
Decision Date2021-05-24
PMAP980044
SupplementS056
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SEIKAGAKU CORP. 6-1, Marunouchi 1-chome, chiyoda-ku tokyo 100-0-0005

Supplemental Filings

Supplement NumberDateSupplement Type
P980044Original Filing
S056 2021-04-28 30-day Notice
S055 2021-03-17 30-day Notice
S054 2020-10-13 30-day Notice
S053 2020-06-30 30-day Notice
S052
S051 2018-12-20 30-day Notice
S050 2018-11-06 30-day Notice
S049 2018-10-16 30-day Notice
S048 2018-07-11 30-day Notice
S047 2018-05-18 Real-time Process
S046 2018-05-10 30-day Notice
S045 2018-04-25 30-day Notice
S044
S043 2018-02-13 30-day Notice
S042 2018-01-11 30-day Notice
S041 2017-11-14 30-day Notice
S040 2017-06-30 30-day Notice
S039 2017-06-29 135 Review Track For 30-day Notice
S038 2017-02-28 30-day Notice
S037 2017-02-24 30-day Notice
S036 2016-12-23 30-day Notice
S035 2016-08-19 30-day Notice
S034 2016-08-16 30-day Notice
S033
S032 2016-04-19 30-day Notice
S031 2016-02-23 30-day Notice
S030 2015-12-09 30-day Notice
S029 2015-11-10 30-day Notice
S028 2015-10-30 Normal 180 Day Track
S027 2015-07-08 Panel Track
S026 2015-06-17 30-day Notice
S025 2015-04-07 Normal 180 Day Track No User Fee
S024 2014-11-24 Normal 180 Day Track
S023 2014-11-21 30-day Notice
S022 2014-11-20 30-day Notice
S021 2014-11-19 30-day Notice
S020 2014-11-18 30-day Notice
S019 2014-08-29 30-day Notice
S018 2014-05-01 30-day Notice
S017 2013-12-18 30-day Notice
S016 2013-06-28 30-day Notice
S015 2013-06-12 30-day Notice
S014 2012-08-20 30-day Notice
S013 2012-04-04 30-day Notice
S012 2010-03-11 135 Review Track For 30-day Notice
S011
S010 2009-08-27 30-day Notice
S009 2009-02-26 Normal 180 Day Track No User Fee
S008 2008-07-30 30-day Notice
S007 2008-07-21 135 Review Track For 30-day Notice
S006 2007-01-30 Special (immediate Track)
S005 2006-08-01 135 Review Track For 30-day Notice
S004 2006-07-26 30-day Notice
S003 2004-09-14 Normal 180 Day Track
S002 2004-06-07 Normal 180 Day Track
S001 2004-04-29 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05060548950057 P980044 000
05060459970120 P980044 000
M717715644440 P980044 019
04987541301314 P980044 027

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